MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PERFORM GLENOIDS INSTR. COMMON BOX CIRCULAR REAMERS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number YKAD210A

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.

Event Description

It was reported that the kit was found missing when preparing for surgery.The error was noticed on the day of the surgery shortly before the start of the surgery and the patient was already under anesthesia.The missing kit was immediately delivered by cab, but due to the distance to the hospital & the required preparation time of the anesthesia, it was necessary to have the patient come out of anesthesia and be re-anaesthetized later.The implantation of the shoulder endoprosthesis itself was successful.

• Brand Name: AEQUALIS PERFORM GLENOIDS INSTR. COMMON BOX CIRCULAR REAMERS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15954938
• MDR Text Key: 305358071
• Report Number: 3000931034-2022-00382
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: YKAD210A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 80